Fighting schistosomiasis

Over 232 million people in Africa suffer from schistosomiasis, a tropical worm disease. It is estimated that more than 200,000 people die each year as a result of this chronic parasitic condition, which makes schistosomiasis one of the most devastating neglected tropical diseases (NTD) in terms of public health burden and economic impact. Schistosomiasis is prevalent primarily in the tropical and subtropical areas of sub-Saharan Africa, and is considered to be the third highest burden among Neglected Tropical Diseases. In these regions, the vast majority of the population has no access to clean water and sanitary installations, which also contributes to the spread of the disease.

Schistosomiasis is caused by flatworms and is spread through stagnant water. People become infected by the worm larvae in the water while bathing, fishing, playing, washing their clothes, or working on agricultural land. These larvae penetrate human skin and enter the blood vessels, where they grow into adult worms. The female's eggs infest inner organs such as the intestines, bladder, spleen, or liver and often cause severe inflammation. Symptoms include severe abdominal pain, diarrhea and bloody urine or stool. The infection rate is especially high among children, and the chronic symptoms that result are particularly serious. For example, schistosomiasis stunts growth and contributes to malnutrition, causing learning disabilities and anemia in children.

Praziquantel, which was developed by Merck KGaA, Darmstadt, Germany in the 1970s as part of a research collaboration, is the only active ingredient to treat all forms of schistosomiasis and is a well-tolerated drug. Since 1983, it has been on the Model List of Essential medicines published by the World Health Organization (WHO).

Managing and monitoring

In 2007, we launched our Praziquantel Donation Program (MPDP) in partnership with WHO. This project was originally intended to run for a period of 10 years, but we have decided to continue the fight until the parasitic disease schistosomiasis has been eliminated in Africa. In order to reach this goal, we pledged in 2012 to significantly expand our donation by a tenfold increase of up to 250 million praziquantel tablets per year. Our efforts to fight schistosomiasis reflect the United Nations Millennium Development Goals  as well as the WHO strategic NTD roadmap ; they are also part of the London Declaration , an initiative to fight neglected tropical diseases launched by the Bill & Melinda Gates Foundation in 2012.

In close collaboration, WHO and Merck KGaA, Darmstadt, Germany each provide their respective expertise to the MPDP. The company donates Cesol® 600mg praziquantel tablets to WHO. We produce quality-assured praziquantel and ship the tablets to the respective countries, where WHO in turn manages, monitors, and documents the local distribution of the tablets and works with local authorities to administer the treatment at schools. WHO is also responsible for supplying local data on morbidity rates and treatment frequency in the countries in which the MPDP has been rolled out. The data for each country can be found in the WHO PCT databank which is the global repository of preventive chemotherapy treatments. A steering committee consisting of representatives from WHO and the company convenes twice a year in order to review the program's progress and decide on its future course. This committee also advises on the allocation of tablets for each country.

Since the start of the program, Merck KGaA, Darmstadt, Germany has donated over 200 million tablets. To date, more than 54 million people have been treated, mainly school-aged children. In 2013, we have donated around 50 million tablets for twelve African countries. We produced around 75 million tablets in 2014, more than 72 million of which were supplied to 20 African countries by the year's end, a collaborative effort with the World Health Organization.

Research

Within the scope of a public-private partnership  (PPP), the company is researching a formulation of praziquantel for small children. Praziquantel tablets in their current form are suitable for adults and children over the age of six; for children younger than six, it is currently not possible to properly treat the disease.

As part of the donation program expansion, Merck KGaA, Darmstadt, Germany is also working to optimize the formulation of the drug. For instance, our researchers are also working on a film coating to make praziquantel tablets easier to swallow as well as more resistant to long transport times.

Educating people

We support an awareness program at schools in Africa that uses comic booklets and posters to explain the causes of schistosomiasis, teaching pupils how to prevent the disease. Following the success of the pilot projects, the program was extended in 2013 to Senegal and Malawi. In addition to 75,000 informational posters on schistosomiasis, we provided one million educational booklets  in total; 250,000 of these went to Malawi and the rest to Senegal. In collaboration with WHO, we are funding the translation of the booklets that are already available in English and French into Swahili, Arabic and Portuguese.

During the 2013-2014 period, the company also helped the Uraha Foundation Germany set up a local radio station in the north of Malawi. Radio Dinosaur  has been broadcasting since the end of 2014; it provides information on politics, environmental issues, history, culture, and health, doing so in the local languages of KyaNgonde and ChiTumbuka. Among other activities, Merck KGaA, Darmstadt, Germany is funding the production of broadcasts that educate people about schistosomiasis.

Fighting schistosomiasis worldwide

In May 2014, Merck KGaA, Darmstadt, Germany called for different NTD constituencies to form the Global Schistosomiasis Alliance (GSA ). This initiative focuses and coordinates efforts to address remaining gaps and challenges in order to meet the schistosomiasis elimination target worldwide. In December 2014, the company organized the first meeting of the GSA at the UN Conference Centre in Addis Ababa, Ethiopia. During this roundtable, the key founding partners of the GSA introduced themselves to an expert audience from all over the world. Besides us, these founding partners include, among others, the Bill and Melinda Gates Foundation , the Schistosomiasis Control Initiative , the United States Agency for International Development , and World Vision International .

Goals: Fighting schistosomiasis with praziquantel

 

 

 

 

 

 

 

 

 

 

Goal

Action

By?

Status in 2013 and 2014

Status

Eliminate schistosomiasis in African school children

Provide tablets containing praziquantel free of charge to treat school children in Africa

Ongoing

Since 2007, more than 50 million patients have been treated, primarily school-aged children.

 

Incrementally increase annual tablet donation by a factor of ten, to up to 250 million

End of 2016

In 2014, we produced around 75 million tablets, of which more than 72 million were supplied to 20 African countries by the year's end, a collaborative effort with the World Health Organization.

 

Optimize the praziquantel formulation

End of 2014

We have finished developing the formulation. The dossier has to be submitted to the regulatory authorities for marketing authorization.

 

Research a new praziquantel formulation for children under 6 years old.

End of 2014

The Phase 1 clinical trial was conducted in South Africa.

Legend: Achieved In progress Not achieved New goal

DISCLAIMER

Publication of Merck KGaA, Darmstadt, Germany.

In the United States and Canada the subsidiaries of Merck KGaA, Darmstadt, Germany operate under the umbrella brand EMD.

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